On May 17, 2021 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported an exclusive license and collaboration agreement with Ji Xing Pharmaceuticals (Ji Xing) to develop and, if approved, commercialize the investigational drug etripamil in patients with paroxysmal supraventricular tachycardia (PSVT) and additional cardiovascular conditions in Greater China (Press release, Milestone Pharmaceuticals, MAY 17, 2021, View Source [SID1234580243]). Ji Xing is a biotechnology company headquartered in Shanghai and backed by RTW Investments, LP (RTW) focused on advancing innovative medicines in China.

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"This agreement marks an important step toward realizing our vision for etripamil to benefit patients living with PSVT globally while strengthening our balance sheet and executional capabilities through partnership," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We look forward to partnering with the talented team at Ji Xing to develop and commercialize this promising therapy in the licensed regions."

"Etripamil has the potential to change the treatment paradigm for PSVT and could serve as a meaningful new therapeutic option for patients," said Peter Fong, Chief Executive Officer of Ji Xing and Head of Company Creation at RTW. "We are delighted to expand Ji Xing’s cardiovascular focus by partnering with Milestone and look forward to unlocking the full therapeutic potential of etripamil for patients with PSVT in China."

Under the terms of the agreement, Milestone will grant Ji Xing an exclusive license to develop and, if regulatory approval is obtained, commercialize etripamil in patients with PSVT in Greater China. Milestone will receive an upfront cash payment consisting of $15 million and a $5 million equity investment by RTW. In addition, Milestone is eligible to receive up to $107.5 million in milestone payments and royalties on future sales of etripamil in Greater China. Milestone will supply etripamil and delivery devices to Ji Xing. Ji Xing will be responsible for development and commercialization costs in Greater China.

About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning that affects approximately two million Americans. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Etripamil

Etripamil, Milestone’s lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and a Phase 2 proof-of-concept trial is now underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).

On May 17, 2021 Landos Biopharma, Inc (NASDAQ: LABP), a clinical-stage biopharmaceutical company focused on the discovery and development of therapeutics for patients with autoimmune diseases, and LianBio, a biotechnology company dedicated to bringing paradigm-shifting medicines to patients in China and other major Asian markets, reported an exclusive collaboration and license agreement for the development and commercialization of omilancor and NX-13 in Greater China (mainland China, Hong Kong, Taiwan and Macau) and select Asian markets (Press release, LianBio, MAY 17, 2021, View Source [SID1234580242]). Omilancor is a novel, oral, gut-restricted LANCL2 agonist in development for the treatment of ulcerative colitis (UC), Crohn’s disease (CD) and Eosinophilic Esophagitis (EoE). NX-13 is a novel, oral, gut-restricted NLRX1 targeting compound in development for the treatment of UC and CD.

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"We are excited to collaborate with LianBio to strategically integrate their clinical and operational expertise in major Asian markets as we expand into global development programs with our innovative autoimmune disease pipeline," said Josep Bassaganya-Riera, Chairman, President and Chief Executive Officer of Landos. "Our lead product candidates, omilancor and NX-13, are designed to have critical advantages over current therapies, including the capacity to target key and novel pathways specifically linked to immune function. The opportunity to capitalize upon LianBio’s resources in Asian markets will enable us to leverage the full value of our assets globally and bring our potentially more effective and better tolerated first-in-class oral therapeutics to patients with UC and CD in Greater China and select Asian markets."

Under the terms of the collaboration, LianBio will receive exclusive rights to develop and commercialize omilancor and NX-13 in Greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia, and the Philippines. Landos will receive an upfront cash payment of $18 million and is eligible to receive development and commercial milestone payments of up to $200 million. Landos is also eligible to receive tiered low double-digit royalties based on net sales of omilancor and NX-13 in the licensed territories. LianBio will participate in future global Phase 3 trials of omilancor and NX-13 by enrolling a meaningful number of patients in these studies. LianBio will fund development and commercialization expenses in the collaboration territory, and Landos will continue to fund all development and commercialization expenses in all other geographies.

"We believe Landos’ differentiated approach to the discovery and development of first-in-class oral therapeutics to target novel immunometabolic pathways has the potential to transform the treatment paradigm for CD, UC and other autoimmune diseases," said Konstantin Poukalov, Managing Director, Perceptive Advisors and Executive Chairman, LianBio. "With inflammatory bowel disease incidence projected to significantly increase throughout Asia over the coming decade, we look forward to partnering with Landos to address the current and future needs of IBD patients."

On May 17, 2021 Orion Biotech Opportunities Corp. (the "Company") reported the closing of its initial public offering ("IPO") of 20,000,000 units at a price of $10.00 per unit, resulting in total gross proceeds of $200,000,000 (Press release, Orion Biotechnology, MAY 17, 2021, View Source [SID1234580232]). The Company’s units began trading on The Nasdaq Capital Market (the "Nasdaq") under the symbol "ORIAU" on May 13, 2021.

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Each unit consists of one of the Company’s Class A ordinary shares and one-fifth of one redeemable warrant, with each whole warrant entitling the holder thereof to purchase one Class A ordinary share at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the Class A ordinary shares and warrants are expected to be listed on the Nasdaq under the symbols "ORIA" and "ORIAW," respectively.

Orion Biotech Opportunities Corp. is a newly incorporated special purpose acquisition company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with a target in a growth-oriented sector, including technology and media.

Cantor Fitzgerald & Co. acted as the sole book-running manager for the offering. The Company has granted the underwriter a 45-day option to purchase up to 3,000,000 additional units to cover over-allotments, if any.

The offering was made by means of a prospectus, copies of which may be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 5th Floor New York, New York 10022; Email: [email protected].

A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on May 12, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A registration statement relating to these securities has been declared effective by the U.S. Securities and Exchange Commission (the "SEC") on March 24, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported that it is postponing its previously announced investor conference call scheduled to be held on Monday, May 17, 2021, at 2 p.m. Pacific Time (Press release, Adamis Pharmaceuticals, MAY 17, 2021, View Source [SID1234580214]). The company filed a Form 12b-25 with the Securities and Exchange Commission today in order to extend the due date of its Quarterly Report on Form 10-Q for the three months ended March 31, 2021, by five calendar days as permitted by Rule 12b-25 under the Securities Exchange Act of 1934, and is postponing the investor call in light of that filing delay. The company will announce a new date and time for a rescheduled investor call.

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On May 17, 2021 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended March 31, 2021 and provided a business update (Press release, Sonnet BioTherapeutics, MAY 17, 2021, View Source [SID1234580194]).

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"Over the course of the quarter, we have made several advancements across our pipeline products, most notably of which are the completion of non-human primate (NHP) toxicology study of SON-080 and the completion of a repeat dose study of SON-1010 in NHPs," commented Pankaj Mohan, Ph.D., Founder and CEO. "Additionally, we were thrilled to have our abstract detailing data from our NHP study of SON-1010 accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting."

FY 2021 Second Quarter and Recent Corporate Updates

Sonnet provided the following updates on its lead pipeline assets:

The Company successfully completed multiple NHP GLP toxicology studies with SON-1010 (FHAB-IL12) and is generating data to prepare an IND submission to initiate clinical studies in the second half of 2021.

Regarding SON-080, the Company intends to file a US IND to initiate a Phase 1b/2a pilot-scale efficacy study in the Chemotherapy-Induced Peripheral Neuropathy (CIPN) indication during the second half of 2021. Additionally, as part of the recently announced partnership with New Life Therapeutics, the companies intend to file an ex-US IND equivalent for a Phase 1b/2a pilot-scale efficacy study in Diabetic Peripheral Neuropathy (DPN) during the second half of 2021. Going forward, Sonnet will exclusively refer to the low-dose IL-6 programs, namely CIPN and DPN, using the SON-080 designation, the latter of which had previously been known as the SON-081 program.

The Company’s first bispecific candidate, SON-1210 (IL-FHAB-IL15), is undergoing cell line and process development activities. Sonnet expects completion of NHP studies in the second half of this year with an IND submission during the first half of 2022.

Sonnet has manufactured bi-specific preclinical constructs of SON-2014 (GMcSF-FHAB-IL18), as well as IL18-FHAB-IL12 and IL12-FHAB-GMcSF that are being evaluated for in vivo efficacy, biomarker profiles and fluorescence-activated cell sorting (FACS) assessment in single dose and multi-dose preclinical studies. The Company intends to initiate commercial cell line development necessary for future clinical studies, with an IND submission for SON-2014 targeted for the second half of 2022.

Sonnet has added key senior management hires of Richard Kenney, M.D. as Chief Medical Officer and Manuel Dafonseca as Head of Clinical Operations, as the Company prepares to advance its FHAB platform into its first clinical study.

"During the quarter, we were able to successfully draw from our at-the-market sales agreement with BTIG and bring in over $10 million of capital to the Company", commented Jay Cross, CFO. "This additional funding will enable us to continue driving our R&D activities forward and furthers our goal of bringing much need therapeutic advancements to patients."

FY 2021 Second Quarter Ended March 31, 2021 Financial Results

●As of March 31, 2021, Sonnet had $6.7 million cash on hand.
●As previously announced, on February 5, 2021, Sonnet entered into an at-the-market sales agreement with BTIG, LLC, for an aggregate offering of up to $15.9 million. Through March 31, 2021, the Company sold an aggregate of 4,021,561 shares for net proceeds of $10.2 million to Sonnet. The company has not sold shares though this facility since March 12, 2021.
●Research and development expenses were $3.8 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $2.5 million was primarily due to increased expenditures for the development of the cell line for IL12-FHAB and IL12-FHAB-IL15

General and administrative expenses were $2.2 million for the three months ended March 31, 2021, compared to $1.3 million for the three months ended March 31, 2020. The increase of $1.0 million was primarily due to an increase in insurance expense of related to directors and officer’s insurance, and in increase in payroll and share-based compensation expense to support our expanded operations.